Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer

NCT07422597 | Recruiting

• 1 other identifier: REK KULMU 927238
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 3

Brief Summary

Thousands of men take a PSA test to investigate whether they have prostate cancer every year. For the vast majority, the test is normal and further investigations are not necessary. In others, the test is sufficiently elevated that men are referred for further investigations. Most men with an elevated PSA are offered an MRI examination of the prostate gland, and for some, a tissue sample of the prostate is also recommended if the suspicion of cancer is high enough. Although this comprehensive investigation reveals most clinically significant , or dangerous cases of cancer, many indolent, or "harmless" cancer cases are also detected, which would not have caused the man any harm during his lifetime (approximately 20% of all prostate cancer diagnoses diagnosed in current clinical practive). Cancer treatment is not recommended for such cases, but for many men, the diagnosis and subsequent follow-up can cause him and his family anxity and concern. In addition, prostate biopsies are unpleasant for the patient and the investigation process is resource-intensive for both the man and the health care service. Risk stratification uses machine learning methods to better identify the men who require further investigations with MRI and tissue samples. In this project, the investigators investigate whether the best risk stratification tools are non-inferior in detecting clinically significant prostate cancer compared to current practice, and whether they lead to fewer tissue samples, MRI scans, less health anxiety, and better cost-effectiveness.

Conditions

Prostate Cancer

Keywords

Suspected prostate cancer; Elevated PSA

Outcome Measures

Primary Outcomes (1)

• Detection of clinically significant prostate cancer

  The study examines whether the risk calculator strategy gives non-inferior detection of csPCa compared with performing an MRI upfront in all men. csPCa defined as International society of Urological pathology grade group (ISUP GG) \>1.

  During the initial diagnostic work-up (up to 6 weeks)

Secondary Outcomes (10)

• Detection of clinically insignificant prostate cancer

  During the initial diagnostic work-up (up to 6 weeks)

• Numbers of prostate biopsy sessions required

  1 year after completion of inclusion

• Numbers of prostate MRIs required

  1 year after completion of inclusion

• Quality of life effect of decision to perfrom prostate biopsy

  1 year after study inclusion is completed

• Quality of life effect of decision to perfrom prostate biopsy

  1 year after study inclusion is completed

Study Arms (1)

Upfront MRI and Multivariable risk assessment in all men

EXPERIMENTAL

Single group

Device: European Study of screening for prostate cancer risk calculator

Interventions

European Study of screening for prostate cancer risk calculator DEVICE

The ERSPC RCs are the currently best known and most utilised multivariable PCa risk stratification tools. All participating men undergo risk stratification by ERSPC RCs to determine need for MRI and for biopsy.

Also known as: https://www.prostatecancer-riskcalculator.com/, Rotterdam prostate cancer risk calculator

Upfront MRI and Multivariable risk assessment in all men

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• more than 10 years remaining life expectancy
• Suspected localized prostate cancer
• Suspicious DRE (cT2)
• PSA 3-20 ng/ml

You may not qualify if:

• cT3 and/or cT4 (on DRE)
• PSA \>20 ng/ml
• Prior diagnosis of prostate cancer
• Contraindications to MRI or to prostate biopsy
• Medications known to affect serum PSA levels

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Norwegian Cancer Society: collaborator

Study Sites (3)

Sykehuset Levanger

Levanger, 7601, Norway

NOT YET RECRUITING

Orkdal sjukehus

Orkanger, Norway

RECRUITING

St Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

Related Publications (10)

• Straat KRV, Hagens MJ, Cools Paulino Pereira LJ, van den Bergh RCN, Mazel JW, Noordzij MA, Rynja SP. Risk Calculator Strategy Before Magnetic Resonance Imaging Stratification for Biopsy-naive Men with Suspicion for Prostate Cancer: A Cost-effectiveness Analysis. Eur Urol Open Sci. 2024 Oct 14;70:52-57. doi: 10.1016/j.euros.2024.08.017. eCollection 2024 Dec.

  PMID: 39483520 BACKGROUND

• Sharp L, Morgan E, Drummond FJ, Gavin A. The psychological impact of prostate biopsy: Prevalence and predictors of procedure-related distress. Psychooncology. 2018 Feb;27(2):500-507. doi: 10.1002/pon.4521. Epub 2017 Oct 11.

  PMID: 28766309 BACKGROUND

• Coyle C, Morgan E, Drummond FJ, Sharp L, Gavin A. Do men regret prostate biopsy: Results from the PiCTure study. BMC Urol. 2017 Jan 26;17(1):11. doi: 10.1186/s12894-016-0194-y.

  PMID: 28125998 BACKGROUND

• Reesink DJ, Schilham MGM, van der Hoeven EJRJ, Schoots IG, van Melick HHE, van den Bergh RCN. Comparison of risk-calculator and MRI and consecutive pathways as upfront stratification for prostate biopsy. World J Urol. 2021 Jul;39(7):2453-2461. doi: 10.1007/s00345-020-03488-2. Epub 2020 Oct 22.

  PMID: 33090259 BACKGROUND

• Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Reducing prostate biopsies and magnetic resonance imaging with prostate cancer risk stratification. BJUI Compass. 2022 Apr 22;3(5):344-353. doi: 10.1002/bco2.146. eCollection 2022 Sep.

  PMID: 35950035 BACKGROUND

• Davik P, Elschot M, Frost Bathen T, Bertilsson H. Repeat Prostate-specific Antigen Testing Improves Risk-based Selection of Men for Prostate Biopsy After Magnetic Resonance Imaging. Eur Urol Open Sci. 2024 Jun 13;65:21-28. doi: 10.1016/j.euros.2024.05.011. eCollection 2024 Jul.

  PMID: 38974460 BACKGROUND

• Patel HD, Remmers S, Ellis JL, Li EV, Roobol MJ, Fang AM, Davik P, Rais-Bahrami S, Murphy AB, Ross AE, Gupta GN. Comparison of Magnetic Resonance Imaging-Based Risk Calculators to Predict Prostate Cancer Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241516. doi: 10.1001/jamanetworkopen.2024.1516.

  PMID: 38451522 BACKGROUND

• Davik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Performance of magnetic resonance imaging-based prostate cancer risk calculators and decision strategies in two large European medical centres. BJU Int. 2024 Mar;133(3):278-288. doi: 10.1111/bju.16163. Epub 2023 Sep 12.

  PMID: 37607322 BACKGROUND

• Hofmann B, Haug ES, Andersen ER, Kjelle E. Increased magnetic resonance imaging in prostate cancer management-What are the outcomes? J Eval Clin Pract. 2023 Sep;29(6):893-902. doi: 10.1111/jep.13791. Epub 2022 Nov 14.

  PMID: 36374190 BACKGROUND

• Thompson IM, Ankerst DP, Chi C, Goodman PJ, Tangen CM, Lucia MS, Feng Z, Parnes HL, Coltman CA Jr. Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst. 2006 Apr 19;98(8):529-34. doi: 10.1093/jnci/djj131.

  PMID: 16622122 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Petter Davik, MD, PhD

  Norwegian University of Science and Technology (NTNU)

  PRINCIPAL INVESTIGATOR

• Magnus Steigedal, PhD

  Norwegian University of Science and Technology, Head of Department (IKOM)

  STUDY CHAIR

Central Study Contacts

Petter Davik, MD, PhD

CONTACT

+47 72829919; petter.davik@ntnu.no

Joakim S Lund, MD

CONTACT

+4772574142; Joakim.Schistad.Lund@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The care provider is blinded to information from the MRI when performing a DRE and calculating risk by the ERSPC 3/4 risk calculators.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, within patient non-inferiority study comparing upfront risk assessments by MRI and risk calculator

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

NO (3)